# K103238: 1.5T Optima MR430S

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Feb 11, 2011 after 101 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971684 (1997). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080048: MSK Extreme MR Scanner, Model AA5000, Oni Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K123068: Optima MR 430S (2012), 0 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0620-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Mar 28, 2013 · Class II · Z-1212-2013: Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

## Indications for use
The Optima MR430s MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

Source page: https://510kreport.com/device/K103238
Methodology: https://510kreport.com/methodology